Microtransplantation With Decitabine and Cytarabine Improves Patient Outcomes in Myelodysplastic Syndromes

Phase 1

Completed

• Conditions: Myelodysplastic Syndromes

• Registration Number: NCT01674985
• Lead Sponsor: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Brief Summary

The purpose of this study is to investigate whether infusion of G-CSF mobilized HLA-mismatched peripheral blood stem cells (G-PBSC) combining decitabine and cytarabine chemotherapy can improve outcomes in myelodysplastic syndromes (MDS) patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2012-08-25
• Study First Submitted QC: 2012-08-28
• Study First Posted: 2012-08-29
• Primary Completion: 2013-10
• Study Completion: 2015-12
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-12
• Last Update Posted: 2016-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• patients 10 to 90 years old with primary or treatment-related MDS or chronic myelomonocytic leukemia;
• International Prognostic Scoring System(IPSS) intermediate-1,intermediate-2,or high risk;
• bone marrow blasts > 11% or <= 10% and poor cytogenetics;
• lack of an HLA-identical donor;
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
• adequate cardiac and hepatorenal functions.

Exclusion Criteria

• have an HLA-identical donor

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
complete remission	six months

Secondary Outcome Measures

Name	Time	Method
disease-free survival	three years

Trial Locations

Locations (1)

Affiliated Hospital of Academy of Military Medical Sciences; 🇨🇳 Beijing, Beijing, China